Novartis Gains U.S. Approval of Lung Cancer Treatment

April 29 (Bloomberg) -- Novartis AG won U.S. approval of
its treatment for patients with advanced non-small cell lung
cancer.

The drug, ceritinib, gained marketing clearance about four
months ahead of the expected decision date because it has the
potential to offer substantial improvement over existing
therapies, the Food and Drug Administration said today in a
statement. Ceritinib, to be marketed by Basel, Switzerland-based
Novartis as Zykadia, blocks proteins that promote the
development of cancer cells, the agency said.

Lung cancer is the leading cause of cancer-related deaths
in the U.S., the FDA said. An estimated 224,210 new cases will
be diagnosed this year and more than 159,000 Americans will die
from the disease, according to the National Cancer Institute.
Zykadia is approved for a small number of patients who have a
certain gene mutation.

“Today’s approval illustrates how a greater understanding
of the underlying molecular pathways of a disease can lead to
the development of specific therapies aimed at these pathways,”
said Richard Pazdur, director of the Office of Hematology and
Oncology Products in the FDA’s Center for Drug Evaluation and
Research. “It also demonstrates the FDA’s commitment to working
cooperatively with companies to expedite a drug’s development,
review and approval, reflecting the promise of the breakthrough
therapy designation program.”

Breakthrough Designation

Zykadia is the fourth drug to receive approval under the
FDA’s breakthrough therapy designation reserved for medicines
that show early promise to provide a substantial improvement
over existing treatments. The status directs the agency to work
closely with the drugmaker to bring the product to market faster
than other therapies.

The drug may generate $423 million in sales in 2018,
according to the average estimate of seven analysts compiled by
Bloomberg. Non-small cell lung cancer accounts for about 85
percent of all lung cancer cases, though just two percent to
seven percent of patients have a mutation of the ALK gene
Zykadia targets, the FDA said.

Zykadia’s approval is based on the medicine’s ability to
shrink tumors and Novartis must prove it benefits patients to
keep the drug on the market. Those treated with Zykadia must
have previously tried New York-based Pfizer Inc.’s Xalkori.

Common side effects include diarrhea, nausea and vomiting.

“The approval of Zykadia less than three and a half years
after the first patient entered our clinical trial exemplifies
what is possible with a highly focused approach to drug
development and strong collaboration,” Alessandro Riva, global
head of oncology development and medical affairs at Novartis,
said in a statement.